Principal Engineer - Medical Devices​/Drug Delivery Devices

Principal Engineer – Medical Devices/Drug Delivery Devices

Onsite client, Monday–Friday, 8‑5. Occasional evening work 1–2 x per month. Pre‑planned travel abroad – candidates must be able to travel internationally.

Lead technical teams in the development of drug delivery devices including needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro‑infuser delivery pump systems. The Principal Engineer will work closely with cross‑functional teams to develop detailed engineering specifications, device design, support verification and validation, and regulatory submissions.

Responsibilities:

• Work cross‑functionally with Marketing, Operations, and Development teams.
• Create and assess product requirements to determine technical coverage and proper subsystem integration.
• Develop and execute project plans and schedules.
• Develop, review, and approve architecture documents, design documents, specifications, development plans, characterization plans, verification and validation plans, and other related product development documents.
• Provide deep technical assistance for junior engineers.

Skills and Experience:

• BS in Engineering (or equivalent) with at least 10 years of experience in a medical device organization.
• Led projects from development through 510(k) and PMA approval.
• Strong background in engineering and commercialization of electro‑mechanical medical devices.
• Experience with material & test specifications, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC optimization & validation (IQ, OQ, PQ), and FMEA.
• Product design/development (design control) from concept to launch for EU EMEA/CE Mark and US FDA/PMA/510(k) submissions.
• Experience in drug/device combination product design and development.
• Knowledge of Quality System Regulation (21 CFR 820), ISO 14971, EU Medical Device requirements (Council Directive 93/42/EEC), and EN 60601.
• Small‑scale device assembly experience.
• Strong problem‑solving, risk assessment, and risk‑management skills.
• Ability to manage multiple projects in a deadline‑driven environment.

Basic Qualifications:

• Doctorate & 3 years experience OR Masters & 5 years OR Bachelors & 7 years OR Associates & 12 years OR High School/GED & 14 years.

IMPORTANT NOTE: Qualified candidates with a strong background in Electrical Engineering, Mechanical Engineering, or general Engineering will be considered.